Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery

Phase 3

Recruiting

• Conditions: Ureter Cancer; Benign Renal Neoplasm; Calculus of Kidney and Ureter; Congenital Ureteric Anomaly; Other Specified Disorders of Kidney and Ureter; Ureteric Reflux; Benign Neoplasm of Ureter; Renal Cancer
• Interventions: Drug: lidocaine infusion; Drug: spinal analgesia with morphine and bupivacaine

• Registration Number: NCT06349668
• Lead Sponsor: Hans Bahlmann

Brief Summary

The goal of this clinical trial is to learn whether the addition of spinal analgesia leads to superior recovery in patients undergoing robotic-assisted laparoscopic upper urinary tract surgery under general anesthesia. The main questions it aims to answer are:

* Is the decrease in wellbeing as quantified by the patient-centered outcome scale "Quality of Recovery 15" (QoR-15), from baseline to the first day after surgery (POD 1), at least 8.0 points less in patients receiving spinal analgesia in addition to general anesthesia?

* Does spinal analgesia result in improved recovery as quantified by QoR-15 at POD 7, the incidence of postoperative pain at rest and at mobilization, nausea and vomiting, the need for opioid analgesics, time out-of-bed, length of stay and the incidence of complications?

* Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery?

* Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery?

Participants will be randomized to receive either spinal analgesia with bupivacaine and morphine preoperatively or an intravenous infusion with lidocaine intraoperatively.

QoR-15 and other markers of recovery will be registered using structured interviews preoperatively, at POD1 and POD7. In addition, patients will record pain at rest and at mobilization three times daily in a diary.

In a subgroup of patients advanced hemodynamic parameters will be recorded using pulse-contour analysis before, during and after surgery. Blood samples will also be collected in these patients at fixed intervals and analyzed for amongst others inflammation and cardiac dysfunction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-24
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-05
• Study Start: 2024-04-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• The patient is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals
• The patient gives oral and written informed consent after having received oral and writen information about the study

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Exclusion Criteria

• The patient has a ASA-class of IV or above
• The patient is a minor or declared incompetent, has severe psychiatric disease or is expected not to be able to understand the study information due to severe restrictions in vision, hearing, cognition, reading or Swedish language abilities
• The patient is a female who is pregnant or breastfeeding
• The patient is a pre-menopausal female who has not undergone sterilisation, hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy, and is not using highly-effective contraception with low user-dependency and cannot provide a negative pregnancy test
• The patient is scheduled for emergency surgery
• Research staff not available
• Scheduled significant simultaneous surgery on another organ
• The anesthesiologist in charge has planned spinal or epidural analgesia
• The patient has clear contraindications to spinal analgesia, e.g. severe coagulopathy, severe aortic stenosis, previous back surgery with rods, or spinal analgesia can be expected to be technically challenging (severe obesity, severe scoliosis)
• The patient has clear contraindications to lidocaine infusion, e.g. proven allergy to local anesthetics, renail failure (eGFR < 30), hepatic failure caused by acute hepatitis or cirrhosis (Child-Pugh B or higher, severe cardiac arrythmias or insuffiency (NYHA IIIb or higher)
• The patient has previously participated in the trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine infusion	lidocaine infusion	intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight)
spinal analgesia	spinal analgesia with morphine and bupivacaine	single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery

Primary Outcome Measures

Name	Time	Method
QoR-15 score at postoperative day 1	First day after surgery	Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.

Secondary Outcome Measures

Name	Time	Method
Length of stay at the PACU	Length of stay at the PACU (from first to final recording of any vital sign by the electronic patient data management system), up to 30 days
"Time out-of-bed" on POD 1-3	First, second and third day after surgery
Incidence of pruritus	From first until seventh day after surgery
Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours of induction of anesthesia	From induction of anesthesia until 48 hours after induction of anesthesia
Fraction of patients needing norepinephrine before start of surgery	From anesthesia induction until start of surgery (first incision or start of endoscopy, whichever comes first)
Pain (NRS) in rest and during motion at POD 7	Seventh day after surgery	Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain.
Amount of opioids administred at the PACU	During stay at the PACU (from first to final recording of any vital sign by the electronic patient data management system), up to 30 days	Amount of opioids administered at the PACU expressed in mcg/kg morphine equivalents as recorded on the post-anesthetic chart.
QoR-15 score preoperatively	Any time between inclusion and the night before surgery	Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.
QoR-15 score at postoperative day 7	Seventh day after surgery	Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.
Pain (NRS) in rest and during motion 2hrs after arrival to the PACU	2 hrs after arrival to the PACU	Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain.
Time from arrival in the OR to start of surgery	Time from entering the OR to first incision or start of endoscopy, whichever comes first, up to 4 hrs.
Incidence of unplanned termination of the lidocaine infusion	Intraoperatively
Percentage of patients with PONV requiring treatment at 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay	At 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay
Pain (NRS) on POD 1-3	First, second and third day after surgery	Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain.
First POD passing gases	From first until seventh day after surgery
Length of stay	From first until thirtieth day after surgery	Length of stay in calendary days
Requirement for opioids after discharge	From first until seventh day after surgery	Y/N, based on a telephone interview
Intraoperative Cardiac Index	Intraoperative	Cardiac output corrected for Body Surface Area expressed in L/min/m2
Intraoperative Pulse Pressure Variation	Intraoperative	Determined as the ratio of the difference between the maximal and minimal values of pulse pressure over the mean of these two values and expressed as a percentage
Time from end of surgery until leaving the OR	Time from end of surgery (removing of surgical drapes or finishing of endoscopy, whichever comes last) until leaving the OR, up to 4 hrs
Amount of remifentanil in patients given remifentanil	Intraoperatively	Amount of remifentanil during anesthesia in patients given remifentanil expressed in mcg/kg/min as recorded on the anesthetic chart.
Amount of intraoperative opioids in patients not receiving remifentanil	Intraoperatively	Amount of intraoperative opioids in patients not receiving remifentanil expressed in mcg/kg/min morphine equivalents as recorded on the anesthetic chart.
DAOH30	From first until thirtieth day after surgery	Days Alive and Out of Hospital defined as the number of full calendary days where the patient is not admitted to a hospital and not deceased
Postoperative complications untill POD 30	From first until thirtieth day after surgery
Amount of opioids administered during the first 24 hours at the ward	During the first 24 hours at the ward	Amount of opioids expressed in mcg/kg morphine equivalents administered during the first 24 hours at the ward as recorded on the ward chart.
Lowest MAP within 10 minutes after induction of anesthesia	Within 10 minutes after induction of anesthesia
Highest MAP within 10 minutes of abdominal insufflation	Within 10 minutes of abdominal insufflation
Average infusion rate of norepinephrine, in patients receiving norepinephrine, before start of surgery	From anesthesia induction until start of surgery (first incision or start of endoscopy, whichever comes first) until end of anesthesia (extubation), up to 48 hours
Intraoperative dynamic arterial elastance	Intraoperative	Determined as Pulse Pressure Variation divided by Stroke Volume Variation
First POD passing stool	From first until seventh day after surgery
Average infusion rate of norepinephrine, in patients receiving norepinephrine, after start of surgery	From start of surgery (first incision or start of endoscopy, whichever comes first) until end of anesthesia (extubation), up to 48 hrs
Intraoperative Cardiac Power Index	Intraoperative	Cardiac Power Output corrected för Body Surface Area, expressed in Watt/m2, with higher values implying better cardiac performance.
Intraoperative Systemic Vascular Resistance Index	Intraoperative	Intraoperative Systemic Vascular Resistance corrected for Body Surface Area
Intraoperative fluid balance	Intraoperatively	Intraoperative fluid balance as recorded on the CRF in ml, defined by the estimated sum of administered fluids minus estimated bleeding, diuresis and other measurable losses.
Time with low blood pressure during anesthesia	Intraoperatively
Intraoperative Stroke Volume Index	Intraoperative	Stroke volume corrected for Body Surface Area expressed in mL/m2
Intraoperative Stroke Volume Variation	Intraoperative	Determined as the ratio of the difference between the maximal and minimal values of stroke volume over the mean of these two values and expressed as a percentage
Intraoperative heart rate	Intraoperative
Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of surgery)	Intraoperatively (later than 15 minutes after start of surgery)
Intraoperative dPmx	Intraoperative	Maximum increase in arterial pressure during a cardiac cycle, expressed in mmHg/second, with higher values implying better cardiac contractility.
Biochemical markers of inflammation	Day of surgery and first and third day after surgery.	To be specified later during the study (samples are stored for later analysis)

Trial Locations

Locations (1)

University Hospital Linköping; 🇸🇪 Linköping, Sweden